Enhancing CKD health: Kidney Awareness Registry and Education-2 (KARE-2) trial Abstract Chronic kidney disease (CKD) is common, causes excess mortality and morbidity, and is associated with socio-demographic disparities with respect to prevalence and clinical outcomes. Measures such as glycemic control in persons with diabetes, blood pressure control, and reduction of proteinuria with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) can help delay CKD decline and decrease CKD-associated morbidity and mortality; however, many individuals with CKD are not benefiting from these scientific advances. This lack of translation may be due in part to very low levels of CKD awareness among providers and patients leading to inadequate primary care provider self-efficacy for delivery of CKD care and poor patient engagement to participate in healthy lifestyles and adhere to medication regimens. To address this need, our multi-disciplinary team has developed and piloted two interventions that increasing awareness among providers and patients and translate that knowledge into more optimal CKD care. The provider intervention is a CKD registry tailored to the entire healthcare team that provides point-of-care decision support regarding CKD management and outside-of care summaries of CKD relevant clinical data to optimize delivery of guideline-concordant CKD care via outreach and population health. The patient intervention is a comprehensive self-management support program that includes low-literacy educational materials, linguistically/culturally tailored automated telephone self-management support (CKD-ATSM), health coaching, and reminder text messages. Our team has successfully piloted both interventions in a pilot feasibility study (NCT01530958) in one academic clinic that serves a low-income, multilingual population. We have since refined the interventions to integrate the registry with the electronic medical record and to include mobile texting in the self-management program. We are now poised to study the effectiveness of the refined interventions on health outcomes among a large diverse, low-income population using the Chronic Care Model framework of health care delivery. We propose a 2x2 factorial randomized controlled trial entitled Kidney Awareness Registry and Education-2 (KARE-2), in which we will randomize 60 providers and 400 patients with CKD in 6 federally qualified community health centers to receive the provider intervention (CKD registry) or usual care and the patient self- management support intervention (CKD-ATSM) or usual care. We will assess the impact of the provider intervention component of KARE-2 (Aim 1); the patient intervention component of KARE-2 (Aim 2); and their interaction (Aim 3) on patient-level clinical outcomes (e.g., blood pressure, CKD decline); provider behavioral outcomes (e.g., provider self-efficacy for CKD management); and patient behavioral outcomes (e.g., CKD awareness, participation in self-management behavior). If one or both KARE-2 interventions are effective at improving health among high-risk patients, they can be disseminated to other delivery systems to change the way CKD care is delivered in the US, leading to reductions in CKD-associated morbidity and mortality.
Chronic kidney disease (CKD) is common, causes excess mortality and morbidity, and is associated with socio-demographic disparities. Delivery of effective CKD management is limited because of low levels of CKD awareness, low provider confidence in delivering CKD care, and poor patient engagement in risk- reduction behaviors. We will assess the impact multifaceted interventions that address these barriers with the goal of improving health among vulnerable patients with CKD.
